Article
Medical Device Vigilance: Ministry Guidelines
Eudamed plays a central role in the vigilance system designed by the Regulation. Most of the articles related to the topic (87, 88, part of 89 and 90) will not be applicable until the database is fully operational.
Consequently, the Ministry of Health had to publish a circular to clarify the vigilance management methods in a period where, in fact, there is no applicable regulation.
Incident and Serious Incident
In the circular, the Ministry adopts and makes applicable the distinction made by Regulation 2017/745 between incident and serious incident.
Incident (also called non-serious incident): any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect;
Serious incident: any incident that directly or indirectly led, might have led or might lead to any of the following consequences: a) the death of a patient, user or other person; b) the temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health; c) a serious public health threat.
Briefly, unlike the Directive, any non-conformity attributable to the product, detected in post-marketing, that may have an impact on the risk-benefit analysis, is considered an incident. A simple incident does not need to be reported to the Ministry (unless an increase in frequency of occurrence or severity is identified), while a serious incident does.
Tools for Vigilance Management
A manufacturer has three tools and consequent duties regarding vigilance:
- Reporting of serious incidents and unexpected side effects;
- Reporting of non-serious incidents and expected side effects (if they constitute a trend);
- Implementation of Field Safety Corrective Actions (FSCA).
Below are the management methods for each individual scenario, as applicable today, pending the full operation of Eudamed.
Reporting of Serious Incidents
In case of a serious incident, the manufacturer must complete the MIR form and transmit it via certified email to:
- Italian Ministry of Health: dgfdm@postacert.sanita.it;
- Office dedicated to medical device vigilance of the competent authority in the country where the incident occurred. The list is available here;
- Notified body, where present.
The report must be made within:
- 15 days from when the manufacturer became aware of the incident;
- Reduced to 10 days in case of death or unexpected serious deterioration in a person’s state of health;
- Reduced to 2 days in case of a serious public health threat.
Reporting of Non-Serious Incidents
As anticipated, not every single event needs to be reported.
The manufacturer must keep a register of non-serious incidents and monitor them – when updating the PSUR – to identify statistical increases in cases and severity, compared to products on the market (and in use). If the events exceed a threshold value in a given period of time, both at the manufacturer’s discretion, a report must be made to the Ministry.
The form to be completed is the Trend report, to be transmitted via certified email to: dgfdm@postacert.sanita.it
Field Safety Corrective Actions
A field safety corrective action is an action taken to prevent or reduce the risk of serious incidents.
It does not necessarily have to be linked to the occurrence of an incident and can be undertaken when deemed necessary by the manufacturer.
A field corrective action consists of two elements:
- FSCA (Field Safety Corrective Action), which gathers the reasons and actions that the manufacturer intends to take. This document is intended for competent authorities and not for the public;
- FSN (Field Safety Notice), which is the document, intended for the public, through which the manufacturer communicates the corrective action and the duties of the users. The FSN must be translated into Italian and the languages of the countries concerned.
The two forms are to be transmitted via certified email to:
- Italian Ministry of Health: dgfdm@postacert.sanita.it;
- Office dedicated to medical device vigilance of the competent authorities in the countries where the product is marketed. The list is available here;
- Notified body, where present.
The notification, to the figures mentioned above, must take place before the implementation of the action (unless urgency requires acting differently).
For greater dissemination, the final version of the safety notice (FSN) is
generally published on the Ministry of Health’s website in the appropriate dedicated page.
This activity is not an obligation for the competent authority.
Therefore, it is the manufacturer’s duty and responsibility to ensure that the safety notice is brought to the attention of users by any means deemed appropriate.
When in Doubt, Ask
This article covers the three most common scenarios related to vigilance. There are specific situations where additional requirements apply, and when Eudamed becomes fully operational, the rules will change significantly.
Given the importance of proper management of medical device vigilance, it is essential to rely on competent figures, such as Sistemir experts, who know how to navigate and can help understand that reporting an incident is a duty that, if well managed, does not compromise the company’s image.
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